Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of… (NCT04583436) | Clinical Trial Compass
UnknownNot Applicable
Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia
Russia90 participantsStarted 2020-09-01
Plain-language summary
This is prospective, randomized study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment below the knee, TASC II type D - femoropopliteal distal bypass with a synthetic ePTDE-grafts and recanalization with angioplasty and stenting using a biomimetic intervowen nitinol stent in patients with symptomatic peripheral arterial disease after 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operated segment and compare the quality of life of patients after the procedure.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults patients (\>18 years old);
* Critical limb ischemia (4-6 Rutherford category);
* Atherosclerotic occlusive lesion of the arteries of the femoropopliteal segment below the knee joint, classified by TASC II as type D, confirmed by computed tomography or arteriography;
* De Novo lession;
* Patient consent;
* Lack of suitable autologous shunting material (GSV)
Exclusion Criteria:
* Juvenile patient (\< 18 years old);
* Pregnancy;
* Asymptomatic lession;
* Acute ischemia;
* Previous treatment on the target lession;
* Non-atherosclerotic lession;
* Severe comorbidity with a life expectancy - less than 2 years;
* Contraindications to antiplatelet therapy;
* Patient participation in another clinical trial;
* Patient refusal to participate in the study;
* Availability of suitable autologous bypass material.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary patency
Timeframe: 24 months
2
Primary assisted patency
Timeframe: 24 months
3
Secondary patency
Timeframe: 24 months
Trial details
NCT IDNCT04583436
SponsorMeshalkin Research Institute of Pathology of Circulation